Study of Red Bull™ Sugar-Free Drink for Reduction of Fatigue in Prostate Cancer Patients Receiving LHRH Agonist Therapy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT01669460
First received: August 16, 2012
Last updated: December 18, 2013
Last verified: December 2013
  Purpose

The purpose of this research study is to find out if Red Bull™ Sugar-Free Drink can reduce fatigue in prostate cancer patients receiving LHRH agonist therapy.


Condition Intervention Phase
Fatigue
Other: Red Bull™ Sugar-Free Drink
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: A Phase II, Open Label Study of Red Bull™ Sugar-Free Drink for Reduction of Fatigue in Prostate Cancer Patients Receiving LHRH Agonist Therapy

Resource links provided by NLM:


Further study details as provided by University Health Network, Toronto:

Primary Outcome Measures:
  • Reduction in overall fatigue as measured by Bruera global fatigue severity scale. [ Time Frame: Within 4 days after completion of intervention (28 days of Red Bull™) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall improvement in quality of life as measured by the Medical Outcomes Study Short-Form (SF-36) [ Time Frame: Within 4 days after completion of intervention (28 days of Red Bull™) ] [ Designated as safety issue: No ]

Enrollment: 20
Study Start Date: July 2012
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Red Bull™ Sugar-Free Drink
Red Bull™ Sugar-Free Drink: two (250mL) cans per day for 28 days
Other: Red Bull™ Sugar-Free Drink
Red Bull™ Sugar-Free Drink two (250mL) cans per day for 28 days

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically confirmed prostate cancer
  • Currently receiving LHRH-agonist therapy for greater than 6 months
  • Measurable fatigue, defined as a score of ≥ 2 on the Bruera global fatigue severity scale
  • Able to swallow Red Bull™ Sugar-Free Drink
  • Life expectancy of at least 1 year
  • Able to read and write in English
  • Willing to limit consumption of alcohol to one drink per day

Exclusion Criteria:

  • Current malignancy or received treatment for a previous malignancy within the last 3 years other than prostate cancer (exceptions are superficial bladder cancer or non-melanoma skin cancer)
  • Myocardial infarction within past 6 months
  • Any unstable serious co-existing medical condition(s) including but not limited to unstable or poorly controlled coronary artery disease, chronic atrial fibrillation, uncontrolled hypertension, uncontrolled diabetes, severe bleeding diseases or immune disorders
  • Evidence of drug or alcohol abuse
  • Known hypersensitivity to caffeine
  • Known history of liver and kidney insufficiencies
  • Known contraindications to Red Bull™ use
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01669460

Locations
Canada, Ontario
University Health Network
Toronto, Ontario, Canada, M5T 1C1
Sponsors and Collaborators
University Health Network, Toronto
Investigators
Principal Investigator: Neil Fleshner, MD, FRCSC, MPH University Health Network, Toronto
  More Information

No publications provided

Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT01669460     History of Changes
Other Study ID Numbers: 12-5041-C
Study First Received: August 16, 2012
Last Updated: December 18, 2013
Health Authority: Canada: University Health Network Research Ethics Board

Additional relevant MeSH terms:
Fatigue
Prostatic Neoplasms
Signs and Symptoms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on July 29, 2014